Methods of deploying a mitral heart valve

ABSTRACT

An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/637,230, filed Mar. 3, 2015, now U.S. Pat. No. 9,289,293, which is acontinuation of U.S. patent application Ser. No. 13/469,975, filed May11, 2012, now U.S. Pat. No. 8,968,394, which claims the benefit of U.S.Patent Application No. 61/485,480, filed May 12, 2011, the entiredisclosures of which are incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, and moreparticularly to a holder that facilitates the implantation of abioprosthetic mitral heart valve, and also to packaging for mitralvalves that facilitates commissure constriction.

BACKGROUND OF THE INVENTION

Heart valve disease is a significant cause of morbidity and mortality,resulting from a number of ailments including rheumatic fever and birthdefects. The natural heart valves are identified as the aortic, mitral(or bicuspid), tricuspid and pulmonary valves, and each has leaflets tocontrol the directional flow of blood through the heart. Worldwide,approximately 300,000 heart valve replacement surgeries are performedannually, and about one-half of these patients receive bioprostheticheart valve replacements, which utilize biologically derived tissues forflexible fluid-occluding leaflets.

The most successful bioprosthetic materials for flexible leaflets arewhole porcine valves and separate leaflets made from bovine pericardiumstitched together to form a tri-leaflet valve. However, flexibleleaflets formed of polymeric, fiber-reinforced, and other syntheticmaterials have also been proposed. The most common flexible leafletvalve construction includes three leaflets mounted to commissure postsaround a peripheral support structure with free edges that projecttoward an outflow direction and meet or coapt in the middle of theflowstream. A suture-permeable sewing ring around the inflow endprovides a platform for anchoring sutures.

Manufacturers stabilize bioprosthetic heart valves with bracketingstructure within jars filled with preserving solution for shipping andstorage prior to use in the operating theater. The valves are stabilizedwith various structures, including a 2- or 3-piece clip and tubularsleeve structure, such as shown in U.S. Pat. No. 6,416,547 to Erickson,et al.

Prosthetic valves typically have a delivery holder centrally located andsutured thereto, and an elongated delivery handle couples to the holderfor manipulating the valve assembly during implant. Because of thestandard delivery direction, the holder is attached to the inflow sidesuch as the sewing ring for mitral valves and to the outflow side suchas the stent cusps or outflow commissure tips for aortic valves.

When delivering a tissue type prosthetic valve in the mitral position,the outflow commissure posts are on the leading or blind side of thevalve and may become entangled with pre-installed anchoring sutures. Thedifficulty of delivery is compounded if the surgery is through aminimally-invasive access channel, a technique that is becoming morecommon. The problem of entanglement is termed “suture looping,” andmeans that the suture that is used to attach or mount the valve to theheart tissue is inadvertently wrapped around the inside of one or moreof the leading commissure post tips. If this occurs, the looped suturemay damage one of the tissue leaflets when tightly tied down, or mayinterfere with the valve implant procedure and prevent maximumcoaptation of the valve leaflets, resulting in a deficiency in theprosthetic mitral valve, requiring an immediate explant.

Some attempts have been made to overcome these problems in currentholders for prosthetic mitral valves. An example of such a holder isU.S. Pat. No. 4,865,600, Carpentier, et al., incorporated herein byreference, which provides a holder having a mechanism that tensionsattachment sutures to constrict the valve commissure posts inwardlyprior to implantation. Another similar device is seen in U.S. Pat. No.6,966,925 to Stobie, also incorporated herein by reference, whichincludes a shaft member positioned on the holder that is axially movablejust prior to valve deployment to cause lengths of the attachmentsutures to extend axially beyond the commissure posts in the fashion ofa tent.

Despite a number of advances, there is still a need in the art for aholder and associated packaging for tissue-type prosthetic mitral valvesthat helps prevent suture looping and is more intuitive in use.

SUMMARY OF THE INVENTION

The present application discloses storage assemblies and systems for aflexible leaflet prosthetic heart valve that helps prevent suturelooping. Each assembly includes a heart valve having an inflow end andan outflow end and a flow axis therebetween. The valve includes aplurality of generally axially-extending flexible commissure posts thatend in tips circumferentially-spaced around the outflow end that supportoccluding flexible leaflets of the valve.

One exemplary assembly features a valve holder that contacts the inflowend of the valve and defines a central aperture. A plurality ofattachment sutures each has a first end that ties to the valve holder, amiddle section that extends from the first end in an outflow directionto one of the commissure post tips, extends to another one of thecommissure post tips, and then extends in an inflow direction back tothe valve holder, and a second end tied to the valve holder. The middlesection crosses the flow axis of the valve between the commissure posttips. An adapter shaped to conform to an inflow side of the valve holderattaches thereto, the adapter defines a central aperture generallyaligned with the valve holder central aperture and has a bridge acrossthe aperture with a threaded nut centered thereon. A commissureconstriction rod is arranged to slide longitudinally through the valveholder aperture and adapter aperture. The rod has a closed bottom endtoward the outflow direction and an open top end toward the inflowdirection surrounded by a rim larger than the aperture of the valveholder but smaller than the aperture of the adapter. A male threadedmember may be screwed through the threaded nut of the adapter until itcontacts the closed bottom end of the rod and forces the rod in anoutflow direction from an undeployed position into contact with themiddle sections of the attachment sutures that cross the flow axis. Therod is then movable farther in the outflow direction to a deployedposition which places the attachment sutures in tension and accordinglypulls the commissure post tips inward.

Both the adapter and valve holder desirably have through holes forreceiving attachment sutures that couple the adapter and valve holdertogether. In one embodiment, the adapter covers locations on the valveholder where the attachment sutures to the prosthetic valve cross overcutting guides on the holder, so as to impede detachment of the holderfrom the valve prior to detachment of the adapter from the holder. Theassembly may further include a disc-shaped clip that removably couplesto the adapter and extends outward from the prosthetic heart valve, apackaging sleeve connected to the clip that substantially surrounds theprosthetic heart valve without touching it, and a storage jar sized toclosely receive the packaging sleeve, wherein the packaging sleeve andstorage jar include anti-rotation features that limit their relativeaxial rotation. The clip defines a central aperture through which thecommissure constriction rod slides, wherein the commissure constrictionrod may include vertical slots that permit passage of the adapterbridge, and the clip includes inwardly-directed lugs that extend withinthe vertical slots. In this way, the clip can only be removed laterallyfrom the adapter after the commissure constriction rod has reached thedeployed position. The clip may comprise two flexible halves that meshtogether along a mid-line in a manner that resists downward movement ofthe valve holder but permits the valve holder and heart valve to beaxially pulled upward free of the holder clip. The commissureconstriction rod preferably includes opposed lockout pawls oncantilevered fingers that flex inward during passage through the valveholder aperture and spring outward underneath the valve holder tomaintain the commissure constriction rod in the deployed position.Indeed, the commissure constriction rod preferably has a second set ofopposed lockout pawls on cantilevered fingers that flex inward duringpassage through the valve holder aperture and spring outward underneaththe valve holder during movement from the undeployed to the deployedposition.

In accordance with another embodiment, a storage system for the flexibleleaflet prosthetic heart valve comprises a storage jar having a bottomportion and a lid, a packaging sleeve that fits closely within thestorage jar and defines a hollow inner space, a disc-shaped clipconnected to the packaging sleeve, and the prosthetic heart valve. Thesystem includes a valve holder that contacts the inflow end of the valveand has a central aperture, the valve holder being removably secured tothe disc-shaped clip such that the heart valve is suspended within thehollow inner space of the packaging sleeve. A bridge is held stationarywith respect to the valve holder and has a threaded nut thereon. Aplurality of attachment sutures each has first and second ends tied tothe valve holder and a middle section that extends along two of thevalve commissure posts and crosses the flow axis of the valve betweenthe commissure post tips. A commissure constriction rod is arranged toslide longitudinally through the valve holder aperture, the rod having aclosed bottom end toward the outflow direction and an open top endtoward the inflow direction. A male threaded member may be screwedthrough the threaded nut of the bridge until it contacts the closedbottom end of the rod and forces the rod in an outflow direction from anundeployed position until it contacts the middle sections of theattachment sutures on the flow axis connecting the valve holder to theprosthetic heart valve. The rod is then movable farther in the outflowdirection to a deployed position which places the attachment sutures intension and accordingly pulls the commissure post tips inward.

In the aforementioned system, the bridge and threaded nut may beintegrally formed with the valve holder. The system may further have anadapter shaped to conform to an inflow side of the valve holder andattached thereto, the adapter defining a central aperture and having thebridge across the aperture with the threaded nut centered thereon.Desirably, the adapter covers locations on the valve holder where theattachment sutures to the prosthetic valve cross over cutting guides onthe holder, so as to impede detachment of the holder from the valveprior to removal of the adapter from the holder. The system may alsoinclude a worm screw having threads that conform to those of thethreaded nut, and a screw couple having engagement structure forcontacting and rotating a proximal end of the worm screw and beingremovably attachable to a proximal end of the commissure constrictionrod. In use, the screw couple may be rotated to cause the worm screw toadvance along the threaded nut and displace the commissure constrictionrod to its deployed position, and the screw couple may be detached fromthe commissure constriction rod and removed, leaving the worm screwengaged with the threaded nut. Moreover, an adapter sleeve that receivesand retains a portion of the screw couple and permits free rotationthereof may be provided, the adapter sleeve having a flange forremovably attaching to a proximal end of the commissure constrictionrod, wherein the screw couple may be rotated from a proximal side of theadapter sleeve. Preferably, the adapter sleeve attaches to the proximalend of the commissure constriction rod with sutures, and the adaptersleeve and screw couple can be removed from engagement with thecommissure constriction rod by severing the sutures. The screw couplemay include internal threading at a proximal end for mating with a malethreaded member.

In a particularly expeditious embodiment, a storage system for theflexible leaflet prosthetic heart valve comprises a storage jar having abottom portion and a lid attached thereon, the prosthetic heart valve, avalve holder including a mechanism for pulling the commissure post tipsinward, and structure within the storage jar that actuates the mechanismfor pulling the commissure post tips inward upon detaching the lid fromthe bottom portion. The structure within the storage jar may include amale threaded member projecting downward from the jar lid, and themechanism for pulling the commissure post tips inward includes a femalethreaded portion that the male threaded member engages.

In the previous system, the valve holder preferably contacts the inflowend of the valve and has a central aperture, and the mechanism forpulling the commissure post tips inward includes a plurality ofattachment sutures each having first and second ends tied to the valveholder and a middle section that extends along two of the valvecommissure posts and crosses the flow axis of the valve between thecommissure post tips. A commissure constriction rod is arranged to slidelongitudinally through the valve holder aperture, the rod having thefemale threaded portion therein. The male threaded member forces the rodin an outflow direction from an undeployed position until it contactsthe middle sections of the attachment sutures on the flow axisconnecting the valve holder to the prosthetic heart valve, the rod isthen being movable farther in the outflow direction to a deployedposition which places the attachment sutures in tension and accordinglypulls the commissure post tips inward.

The commissure constriction rod desirably includes opposed lockout pawlson cantilevered fingers that flex inward during passage through thevalve holder aperture and spring outward underneath the valve holder tomaintain the commissure constriction rod in the deployed position. Thesystem may further have a packaging sleeve that fits closely within thestorage jar bottom portion and a holder clip attached to the top ofpackaging sleeve. The holder clip has a central aperture that retainsthe valve holder suspended over a cavity within the packaging sleevesuch that the prosthetic heart valve resides within the cavity of thepackaging sleeve, and comprises two flexible halves that mesh togetheralong a mid-line in a manner that resists downward movement of the valveholder but permits the valve holder and heart valve to be axially pulledupward free of the holder clip.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is an exploded perspective view of components of an exemplaryprosthetic heart valve storage system;

FIG. 2 is an assembled perspective view of the prosthetic heart valvestorage system showing an external storage jar;

FIG. 3 is a perspective view of a prosthetic heart valve and holderexploded below an adapter and commissure constriction rod from theprosthetic heart valve storage system of FIG. 1;

FIGS. 4A-4C are perspective views of an assembly sequence of theprosthetic heart valve storage system components seen in FIGS. 1 and 3;

FIG. 5 is a perspective view of the assembled components from FIG. 4Cplaced within a storage sleeve and showing a threaded deployment handleadvancing thereover;

FIGS. 6A and 6B are perspective and elevational views showing selectcomponents of the storage system and delivery handle thereover;

FIGS. 7A-7C show a sequence of elevational views which illustrate howthe holder in the system of FIG. 1 constricts the valve commissures tohelp prevent suture entanglement;

FIGS. 8A-8C are several views of a commissure constriction rod used inthe system of FIG. 1;

FIGS. 9A-9C are several views of a storage clip used in the system ofFIG. 1;

FIGS. 10A-10C are several views of an adapter having a threaded nut usedin the system of FIG. 1;

FIGS. 11A-11C are several views of a prosthetic heart valve holder usedin the system of FIG. 1;

FIG. 12 is an exploded perspective view of key components of aprosthetic heart valve storage system similar to that shown in FIGS.1-11;

FIGS. 13A and 13B are perspective views of an assembly sequence of theprosthetic heart valve storage system components seen in FIG. 12;

FIGS. 14A and 14B are perspective and longitudinal sectional views ofthe assembled system components from FIG. 12 prior to deployment of acommissure constriction rod;

FIGS. 15A and 15B are perspective and longitudinal sectional views ofthe assembled system components from FIG. 12 after deployment of thecommissure constriction rod;

FIG. 16 is an assembled perspective view of key components of anotheralternative prosthetic heart valve storage system having an integralworm screw;

FIG. 17 is an exploded perspective view of the components in FIG. 16;

FIGS. 18A and 18B are elevational and plan views of the assembly of FIG.16;

FIGS. 19A and 19B are perspective and longitudinal sectional views ofthe assembled system components from FIG. 16 minus the heart valve priorto deployment of a commissure constriction rod;

FIGS. 20A and 20B are perspective and longitudinal sectional views ofthe assembled system components from FIG. 16 after deployment of thecommissure constriction rod;

FIG. 21 is a longitudinal sectional view of an alternative prostheticheart valve storage system having the capacity to automaticallyconstrict the heart valve commissures upon opening a storage jar;

FIG. 22 is an exploded perspective view of the components of the systemof FIG. 21;

FIG. 23 is a perspective view looking up into a jar lid of the system ofFIG. 21 to illustrate a worm screw integrated into the lid;

FIGS. 24A and 24B are perspective and sectional views of a commissureconstriction rod used in the system of FIG. 21;

FIG. 25 is a perspective view of a packaging sleeve assembly for holdinga heart valve in the system of FIG. 21;

FIG. 26 is a view looking up into a jar lid with the assembly of FIG. 25screwed onto a threaded post therein;

FIG. 27 is an exploded perspective view of the components of aprosthetic heart valve storage system similar to that shown in FIGS.21-22, but with an alternative holder clip attached to the top of apackaging sleeve;

FIG. 28 is a perspective view of the alternative holder clip of FIG. 27;

FIG. 29 shows the prosthetic heart valve storage system components ofFIG. 27 assembled; and

FIGS. 30A and 30B illustrate two steps in a process of removing aprosthetic heart valve from within the packaging sleeve by simplypulling it up past the alternative holder clip.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides an improved heart valve holder fortissue-type prosthetic heart valves that facilitates implantation andreduces the chance of suture entanglement. The holder of the presentinvention is particularly useful for prosthetic mitral heart valveshaving commissure posts on the outflow side supporting flexible leafletstherebetween. The mitral position is such that the outflow end withcommissure posts is the leading end as it advances toward the leftventricle during implantation, and thus the holder is attached to theinflow (i.e., trailing) end of the valve. Delivery of the valve to themitral position involves sliding (parachuting) the valve down aplurality or array of sutures that have been pre-installed around theannulus and then passed through the valve sewing ring. The holder of thepresent invention constricts the valve commissure posts radially inwardand at the same time moves attaching sutures axially to form a steepangle, or tent, thus helping to prevent the leading commissure postsfrom becoming entangled in the array of pre-installed sutures.

FIG. 1 is an exploded perspective view of components of a prostheticheart valve storage system 20. The storage system includes a jarincluding a bottom portion 22 and a lid 24. A schematic flexibleleaflet, typically bioprosthetic, heart valve 26 typically includes asewing ring 28 on an inflow end, and a plurality of commissure posts 30projecting toward an outflow end and supporting flexible leaflets 32across a flow orifice. The remaining components seen in FIG. 1 are usedto retain and stabilize the heart valve 26 within the jar, shownassembled in FIG. 2 with the lid 24 screwed onto the bottom portion 22.

The reader will notice that the bottom portion 22 includes a relativelytall series of external threads 34 that meet with internal threads (notshown) within the relatively tall lid 24. This arrangement is useful forone embodiment described below, although a more traditional jar having ashorter lid with a shorter series of mating threads is typically used.In any event, the jar contains a preservative fluid such asglutaraldehyde which maintains sterility and leaflet flexibility inbioprosthetic heart valves 26 during long-term storage, and thus the lid24 provides a fluid tight seal over the bottom portion 22.

The components of the valve storage system 20 are shown in the variousviews of FIGS. 3-11, and include a valve holder 40 that attaches to theprosthetic heart valve 26, a commissure constriction rod 42, an adapter44, a packaging sleeve 46, and a generally disc-shaped clip 48. Ingeneral, the components assemble in the sequence shown in FIG. 1 suchthat the heart valve 26 is restrained from movement and suspended withinthe fluid-filled jar for shipping and storage prior to use. The mannerin which the components assemble and are used will be described below.

FIG. 3 is an exploded perspective view of the prosthetic heart valve 26and several key components of the system 20; namely, the valve holder40, the commissure constriction rod 42, and the adapter 44. The valveholder 40 attaches to the inflow sewing ring 28 of the valve 26 usingattachment sutures 50. As seen best in FIGS. 11A-11C, the holder 40includes a generally ring-shaped body 52 with a plurality, preferablythree, outwardly-projecting legs 54. The legs 54 each include throughholes 56 and a cutting guide 58 for fastening the attachment sutures 50.More particularly, free ends of attachment sutures 50 pass upward fromthe sewing ring 28 through two of the through holes 56 that flank thecutting guide 58. As seen in FIG. 4A, the free ends of the attachmentsutures 50 are tied together so that a portion crosses over the cuttingguide 58. Although not shown, each one of the free ends loops around aportion of the associated holder leg 54 so that it is secured thereto.

With reference again to FIG. 3, and also FIG. 11B, each of the holderlegs 54 projects outwardly over one of the valve commissure posts 30.There are preferably three attachment sutures 50 that connect the holder40 to the prosthetic heart valve 26. Each one of the attachment sutures50 connects to one of the holder legs 54 and passes downward through thesewing ring 28 and through a fabric portion of the associated commissureposts 30. From there, the attachment suture 50 extends radially inwardfrom a distal tip of the commissure post 30 to an axially centrallocation (not visible) generally along the flow axis of the valve 26,and then from there radially outward to a second commissure post 30. Theattachment suture 50 then extends axially upward through the secondcommissure post 30 and through one of the through holes 56 in a secondholder leg 54, where it is also tied off. In the tri-leaflet valve 26shown, there are three attachment sutures 50 that each have segments 50′extending between two of the commissure posts 30, with the aggregateforming a trefoil shape across the commissure tips. To ensure that theattachment sutures 50 meet at the actual center of the valve, thesegments 50′ overlap in the middle. The segments 50′ of the attachmentsutures 50 that span between the distal tips of the commissure posts 30are arranged generally in a plane and, though tautly threaded throughthe valve 26 prior to use, they do not pull the commissure posts 30inward to any great degree so that the valve can be in a relaxed stateduring a potentially long storage period. As will be described below,tension on the attachment sutures 50 causes inward constriction of thecommissure posts 30, much as was described in U.S. Pat. No. 6,966,925 toStobie.

With reference still to FIG. 3 and the detailed views of FIGS. 11A-11C,the valve holder 40 includes several other features that should benoted. First of all, three downwardly-projecting flanges 60 coincidingwith each of the holder legs 54 extend into the flow orifice defined bythe sewing ring 28. These flanges 60 thus enable a technician to rapidlycenter the holder 40 on the inflow side of the valve 26 when securing itthereto with the attachment sutures 50. Furthermore, the flanges 60provide stability between the holder 40 and attached valve 26 during thedelivery and implantation procedure to help prevent radial misalignmenttherebetween. The holder 40 further includes a contoured or generallyrounded upper face which mates with a concave underside of the adapter44, as will be explained. With specific reference to the plan view ofFIG. 11B, the ring-shaped body 52 has a rounded triangular centralaperture defined by an inner boundary 62. As will be explained further,the inner boundary 62 closely receives the similarly-shaped commissureconstriction rod 42. The holder 40 possesses symmetry (about ahorizontal line 64 in FIG. 11B) such that two of the three spans 66 ofthe body 52 between the legs 54 are identical, while a third span 68 isunique. The two identical spans 66 both include through holes 70 thatreceive sutures for connecting the holder 40 to the adapter 44. Indeed,although the adapter 44 will be described in greater detail below, FIG.10B adjacent to FIG. 11B shows its congruency with the holder 40. Thetwo identical spans 66 have cutout regions 72 that are aligned acrossthe holder 40 and serve to orient the holder relative to the adapter 44,again, as will be explained.

FIG. 4A shows the valve holder 40 secured to the heart valve 26 with theattachment sutures 50. As explained, each pair of free ends of theattachment sutures 50 ties to one of the holder legs 54. Above thevalve, a subassembly of the commissure constriction rod 42 and adapter44 is shown. To better explain these two parts, greater detail is shownin FIGS. 8A-8C and 10A-10C.

The commissure constriction rod 42 seen in FIGS. 8A-8C comprises anelongated body 80 having a closed bottom end 82 and an open topsurrounded by a rim 84. As seen in FIG. 8B, a horizontal section showsthat the body 80 has a rounded triangular configuration. The body 80 isformed by generally vertical sidewalls interrupted by several slots andcutouts. More particularly, two opposed vertical slots 86 substantiallythe entire length of the body 80, opening at the upper rim 84 and endingnear to the closed bottom end 82. The vertical slots 86 engage withelements of the adapter 44 and the clip 48, as will be explained.Additionally, the body 80 includes a pair of opposed assembly fingers 88each of which has two outwardly-projecting pawls—a two-way pawl 90 and alockout pawl 92. Fingers 88 are formed by slits cut into the body 80 andare cantilevered downward so as to be radially flexible. The body 80further includes a pair of opposed lockout fingers 94 that are alsoformed by slits cut into the body so as to be cantilevered upward andradially flexible. The lockout fingers 94 each include a single lockoutpawl 96. Each of the pawls 90, 92, 96 interact with the inner boundary62 of the valve holder 40 during assembly of the components andactuation of the rod 42. More particularly, the peripheral size andshape of the rounded triangular body 80 fits closely within the roundedtriangular inner boundary 62 of the valve holder, with the pawls 90, 92,96 projecting outwardly (see FIG. 8B) so as to provide interference withthe holder inner boundary. The upper rim 84 of the rod 42 extendsoutwardly from the body 80 and is too large to pass through the holderinner boundary 62.

The adapter 44 fits down over the top of the rod 42, as seen bycomparing FIGS. 3 and 4A. The adapter 44, illustrated in detail in FIGS.10A-10C, includes a generally ring-shaped body 100 defining a centralaperture and three outwardly-projecting legs 102. A rounded triangularinner boundary 104 is spanned by a bridge 106 across the middle of theadapter 44. An internally threaded nut 108 resides at the center of thebridge 106. The size of the inner boundary 104 is large enough to fitaround the upper rim 44 of the commissure constriction rod 42 with thebridge 106 passing downward through the vertical slots 86, as seen inFIG. 4A. As mentioned previously, and as seen by a comparison of FIGS.10B and 11B, the shape of the adapter 44 conforms to the shape of thevalve holder 40, and the former ultimately lies on top of the latter andis secured thereto. More particularly, the subassembly of the rod 42 andadapter 44 is lowered down into contact with the valve holder 40 suchthat the adapter legs 102 register with the holder legs 54, and thelower end of the rod 42 projects within the inner boundary 62 of theholder. The adapter 44 covers locations on the valve holder 40 where theattachment sutures 50 cross over the cutting guides 58, which impedesdetachment of the holder from the valve 26 prior to detachment of theadapter from the holder.

FIG. 4B illustrates the subassembly of the commissure constriction rod42 and adapter 44 coupled with the prosthetic heart valve 26 and itsholder 40. As seen in FIG. 10B, the adapter 44 includes a plurality ofthrough holes 110 flanking a pair of cutting guides 112 located onopposite sides of the body 100. The through holes 110 align with thethrough holes 70 in the holder 40 (FIG. 11B) and permit passage ofsutures 114 (see FIG. 4B) which are tied off such that a section spanseach of the cutting guides 112. Each of these attachment sutures 114 issecurely fastened to the adapter 44 such that when severed through thecutting guides 112, removal of the adapter also pulls the attachmentsutures therewith.

Still with reference to FIGS. 10A-10C, the adapter 44 includes a planeof symmetry 116. On opposite exterior edges of the adapter body 100across the plane 116, short lands 118 are each defined between one ofthe outwardly-projecting legs 102 and a small outward bump 120. Thelands 118 provide surfaces which latches 122 on the packaging clip 48engage (FIG. 9A).

The disc-shaped packaging clip 48 shown in detail in FIGS. 9A-9C isshaped generally as the letter “C” with a circular outer periphery 130open at one side leading to an inner boundary 132. A pair of opposedlugs 134 projecting inward from the inner boundary 132 fit within thevertical slots 86 in the rod 42, as can be seen in FIG. 4C. The clip 48further includes a plurality of slots 136 distributed around its outerperiphery for mating with upstanding fingers 138 on the packaging sleeve46, as seen in FIG. 5. As seen in FIG. 9B, the upper surface of thedisc-shaped clip 48 includes a directional indicator 140 pointing awayfrom the opening of the “C” shape. In the illustrated embodiment, theindicator 140 comprises a series of raised ribs that gradually taper tothe left in the form of an arrowhead, although a similar indicator maybe formed from indentations, printing, or the like. The purpose of theindicator 140 will be explained below.

FIG. 5 illustrates the assembled components from FIG. 4C, including theclip 48 coupled down over the adapter 44, placed within the generallytubular though perforated storage sleeve 46. As mentioned above, thefour upstanding fingers 138 on the sleeve 46 engage within thecorresponding slots 136 in the clip 48. This structure stabilizes theprosthetic heart valve 26 that is held by the holder 42, adapter 44, andclip 48. The entire assembly shown in FIG. 5, minus an illustratedthreaded deployment handle 150, is placed within the lower section 22 ofthe storage jar within which is provided a preserving fluid such asglutaraldehyde. The package is sealed by screwing on the lid 24, as seenin FIG. 2.

The packaging sleeve 46 has a plurality of openings or perforationsaround its circumference to permit relatively unimpeded flow ofpreservative fluid therethrough. Also, once removed from the jar, theentire assembly may easily be rinsed with a sterile solution, and theopenings in the side of the sleeve 46 permit the heart valve 26 thereinto be rinsed. The sleeve 46 further includes a plurality ofoutwardly-directed protrusions 152 that are arranged to engageinwardly-directed rails (not shown) on the interior of the jar bottom22. Interference between the protrusions 152 and the jar rails limitsrotation of the sleeve 46 within the jar to a small angular extent. Thisanti-rotation feature permits the threaded deployment handle 150 to beadvanced and screwed into the threaded nut 108 of the adapter 44 withone hand while the other hand holds the jar, without having to otherwisebrace the sleeve 46. It should be understood that various otheranti-rotation configurations between the sleeve 46 and the jar arecontemplated, such as shown in co-pending U.S. Pat. No. 8,839,957,entitled PROSTHETIC HEART VALVE PACKAGING SYSTEM, filed Feb. 14, 2011,whose contents are expressly incorporated by reference herein.

FIGS. 6A and 6B show the assembled components from FIG. 4C minus theheart valve 26 and the distal end of the threaded deployment handle 150.The elevation of the commissure constriction rod 42 relative to thevalve holder 40, adapter 44, and disc-shaped clip 48 is shown. Asmentioned previously, the lower end of the rod 42 projects slightlywithin the inflow end of the prosthetic heart valve 26, but not farenough to contact the flexible leaflets 38. The rod 42 is in itsundeployed configuration. In this position, the inner boundary 62 of thevalve holder 40 (see FIG. 11B) is positioned between the two-way pawl 90and lockout pawl 92 of the assembly fingers 88 on the rod 42 (see FIG.8B). The two-way pawl 90 permits downward passage of the rod 42 throughthe valve holder 40. During assembly, a technician inserts thecombination of the rod 42 and adapter 44 into the holder 40, as seen inFIG. 4A, until the rod reaches this position. Further downward movementof the rod 42 will cause inward movement of the lockout pawl 92 past theinner boundary 62 of the valve holder 40, which then prevents subsequentupward movement of the rod. However, prior to this deployment, thestorage system components securely suspend the prosthetic heart valve 26within the cylindrical space defined within the sleeve 46.

FIGS. 7A-7C show a sequence of elevational views which illustrate howthe valve holder 40 constricts the valve commissures 30. The threadeddelivery handle 150 is advanced downward through the open end of theconstriction rod 42. The male threads on the handle 150 engage thefemale threads on the threaded nut 108 of the adapter 44 (FIG. 10B). Asthe handle 150 advances, as seen in FIG. 7B, the distal end thereofcontacts the closed bottom end 82 of the rod 42 and forces the roddownward. Ultimately, as seen in FIG. 7C, the lower end of the rod 42contacts the trefoil arrangement of attachment sutures 50′ and forcesthem downward also. Because of the finite length of the sutures 50attached to the valve holder 40, this downward force causes them to forma tent shape which pulls the commissures 30 inward. Finally, the rod 42advances far enough such that the upper lockout pawls 96 descend belowthe inner boundary 62 of the valve holder 40, thus preventing upwardmovement of the rod. At this point, the valve holder assembly is fullydeployed and the prosthetic heart valve 26 is ready for attachment topre-installed annulus implantation sutures and parachuted deploymentdown an array of such sutures.

The disc-shaped packaging clip 48 can be easily removed by pulling itoff of the adapter 44. More particularly, pulling the clip in thedirection of the indicator 140 of FIG. 9B causes the downward latches122 to travel over the small bumps 120 (FIG. 10B) on the adapter 44. Theorientation of the adapter 44 in FIG. 10B is the same as of the clip 48in FIG. 9B such that is easy to see how the clip can be disengaged tothe left from the adapter.

The packaging system further includes a safety mechanism whereby theclip 48 cannot be removed until the commissure constriction rod 42 hasbeen deployed downward. More particularly, the inwardly-directed lugs134 on the clip 48 extend within the vertical slots 86 in the rod 42. Asseen best in FIGS. 6A and 7A-7C, removal of the clip 48 from the adapter44 is prevented by the interference between the lugs 134 and slots 86until the rod 42 has descended downward below the level of the clip 48.The upper rim 84 of the rod 42 ultimately contacts the inner boundary 62of the holder 40 and stops downward movement of the rod. At this point,the rod 42 is below the level of the clip 48 which can be removedlaterally.

In use, the packaging system 20 shown in FIGS. 1-11 facilitatesdeployment of the commissure constriction mechanism and thus simplifiesthe preparation of the prosthetic heart valves 26 prior to implantation.The components of the system 20 are coupled together as explained aboveand sealed within the jar as seen in FIG. 2. When ready forimplantation, the surgical team removes the lid 24 from the bottomportion 22, thus exposing the top of the assembly as seen in FIG. 5within the jar. A technician advances the delivery handle 150 downwardinto the open end of the commissure constriction rod 42 until it engagesthe threaded nut 108 on the adapter 44. The technician screws thedelivery handle 150 into the threaded nut 108 until its distal endcontacts the closed bottom end 82 of the rod 42, as seen in FIG. 7B.During this procedure, the preservative fluid may remain in the jar inwhich case the bottom portion 22 must be kept upright. Alternatively,the technician pours the preservative fluid out and can thus hold thejar in any orientation. The anti-rotation protrusions 152 on thepackaging sleeve 46 (FIG. 5) engage the rails on the inner wall of thejar bottom portion 22, thus bracing the assembly from rotation whilescrewing in the handle 150. Another alternative is to remove the entireassembly shown in FIG. 5 from the jar and hold on to the exterior of thepackaging sleeve 46 while screwing in the handle 150.

Just prior to or as the top rim 84 of the rod 42 (FIG. 8A) reaches theinner boundary 62 of the valve holder 40 (FIG. 11B), the upper lockoutpawls 96 on the rod spring outward underneath the holder, which can beheard and felt by the technician. Moreover, further downward movement ofthe rod 42 is prevented which indicates that the valve commissures 30are in the constricted position shown in FIG. 7C. At this point, if notalready done, the technician can remove the entire assembly shown inFIG. 5 from the jar using the handle 150. The packaging sleeve 46 iseasily pulled axially downward so that the upstanding fingers 138 on thesleeve disengage from the slots 136 on the disc-shaped clip 48. Becausethe rod 42 has descended below the level of the clip 48, the clip can beremoved laterally from engagement with the adapter 44, leaving theassembly seen in FIG. 4B in addition to the delivery handle 150.

The surgeon then threads an array of pre-installed implantation suturesaround the periphery of the sewing ring 28 in accordance withestablished practice. Subsequently, the surgeon advances the prostheticheart valve 26 down the parachute-like array of implantation suturesuntil the sewing ring 28 comes in contact with the mitral valve annulus.Because the commissures 30 have been constricted radially inward, thepossibility of suture entanglement is greatly reduced. Furthermore, thetented arrangement of the attachment sutures 50′ and blunt distal tip ofthe commissure constriction rod 42, as seen in FIG. 7C, helps deflectany loose implantation sutures from looping around the commissure tips.

At this point, the sutures 114 holding the adapter 44 to the valveholder 40 can be severed, and the adapter easily removed along with thehandle 150. This also exposes the cutting guides 58 on the valve holder40, which were occluded by the adapter 44. Preventing removal of thevalve holder 40 from the valve 26 until the adapter 44 is removedfurther ensures that the commissures have been constricted, because theadapter 44 cannot be removed until the packaging clip 48 has beenremoved therefrom, which can only happen after the rod 42 has fullydescended.

The delivery handle 150 is useful to control movement of the heart valve26, but after valve contact with the annulus the handle is desirablyremoved to improve access to the space around the valve and facilitatetying off implantation sutures on the visible side of the sewing ring28. Because of the lockout pawls 96 on the commissure constriction rod42, the delivery handle 150 and adapter 44 can be easily removed whilethe commissure constriction mechanism remains in place.

After tying down the implantation sutures, the surgeon then severs theattachment sutures 50 seen in FIG. 4A that couple the holder 40 to theprosthetic heart valve 26. Because one end of each of the sutures 50 issecured to the holder 40, severing the sutures at the cutting guides 58(FIG. 11B) permits the holder and sutures to be pulled free of the heartvalve 26, thus completing the implantation procedure.

FIG. 12 is an exploded perspective view of a subassembly of analternative prosthetic heart valve storage system similar to that shownabove. These components have similar functions to those described above,and thus the same nomenclature will be used.

The subassembly includes a prosthetic heart valve holder 160, acommissure constriction rod 162, an adapter 164, and a packaging clip166. As explained above, the valve holder 160 includesoutwardly-projecting legs 168 that attach to an inflow end of aprosthetic heart valve 170 with sutures 172, as seen in FIGS. 13A and13B. The holder 160 includes a central aperture which closely receivesthe commissure constriction rod 162. As with the above-describedembodiment, the rod 162 displaces axially through the holder 160 andeventually contacts and tensions portions 172′ of the attachment suturesthat extend between valve commissure posts 174 and cross the flow axis.

The adapter 164 also includes a ring-shaped outer body 180 defining acentral aperture and three outwardly-projecting legs 182 that cover thevalve holder legs 168. The adapter 164 features a bridge extendingacross its aperture and having a threaded nut 184 centered thereon. Thethreaded nut 184 projects axially upward from the elevation of thering-shaped outer body 180, and includes lugs 186 that permit a centralcollar 188 of the packaging clip 166 to be snapped to the adapter 164,as seen best in FIG. 15A.

The commissure constriction rod 162 defines a plurality of lockout pawls190 positioned on the ends of flexible fingers formed in the verticalwalls of a body portion 192. The body portion 192 has a closed bottomend and an open top surmounted by an outwardly-extending rim 194. Thesize and shape of the body portion 192 fits closely through the apertureof the holder 160, with the lockout pawls 190 being cammed inward andspringing outward upon passage therethrough. The top rim 194 limitsdownward movement of the rod 162 through the holder 160. The rod 162further defines vertical channels or slots 196.

Similar to the sequence described above, the combination of thecommissure constriction rod 162 and adapter 164, as seen in FIG. 13A, isbrought down over the top of the combination of the valve holder 160 andvalve 170. Although not shown, the adapter 164 couples to the valveholder 160 with attachment sutures. As before, the legs 182 of theadapter 164 cover the valve holder legs 168, and at the same time thesutures 172 that attach the valve holder to the valve 170. The verticalslots 196 of the rod 162 permit passage of the bridge of the adapter164. The packaging clip 166 also fits down along the commissureconstriction rod 162 until the central collar 188 can be snapped ontothe upstanding threaded nut 184 of the adapter 164, as seen in FIG. 13B.

FIGS. 14A and 14B show the assembled components from FIG. 12 prior todeployment of the commissure constriction rod 162, while FIGS. 15A and15B show the commissure constriction rod deployed. The prosthetic heartvalve 170 has been removed for clarity to better show the internalengagement of a threaded delivery shaft 200 with the threaded nut 184and the commissure constriction rod 162. Specifically, advancing thedelivery shaft 200 along the threaded nut 184 eventually causes thedistal end of the delivery shaft to contact the closed bottom of the rod162, forcing the rod downward until the top rim 194 contacts the valveholder 160, as seen in FIG. 15B.

This embodiment also illustrates a feature that permits adaptation ofthe commissure constriction rod 162 for different sizes of heart valves170. In particular, the axial distance that the rod 162 travels in orderto pull the valve commissure posts 174 inward changes for differentsizes of valves; with larger valves requiring a greater axial traveldistance. However, the length of the threaded portion of conventionaldelivery shafts 200 is constant. In order to vary the distance that therod 162 travels, a small axial post 202 extending upward from the closedbottom end is provided. The axial post 202 includes a concave uppersurface that receives and centers the distal end of the delivery shaft200. By varying the axial height of the post 202, the point at which thedelivery shaft 200 engages the commissure constriction rod 162 can beadjusted. For larger valves, the length of the axial post 202 isincreased so that the delivery shaft 200 engages the rod 162 earlier,and causes greater travel. Conversely, for smaller valves, the length ofthe axial post 202 is minimized.

FIGS. 16-18 illustrate key components of another alternative prostheticheart valve storage system 220 having an integrated worm screw 222. Thesystem 220 includes the worm screw 222, a prosthetic heart valve holder224, a commissure constriction rod 226 (two parts), a screw couple 228,and an adapter ring 230. The system 220 functions much like the twoembodiments described above, though a threaded nut 232 is provided onthe valve holder 224 rather than on a separate adapter, and theintegrated worm screw 222 replaces part of the function of the threadedend of a delivery handle.

FIGS. 19-20 illustrate the system 220 components from before and afterdeployment of the commissure constriction rod, and show aspects of theassembly. With reference also to FIG. 17, the valve holder 224 includesa generally ring-shaped body 240 surrounding a central aperture 242 andhaving a plurality, preferably three, outwardly-projecting valveengagement legs 244. As before, each valve engagement leg 244 includes adownwardly-projecting flange 246 for centering the holder 224 within asewing ring on the inflow end of a prosthetic heart valve 248. Each leg244 further includes through holes and cutting guides to permit passageof attachment sutures that extend down the valve commissure posts andacross the outflow end between commissure post tips.

The commissure constriction rod 226 includes a generally tubular body250 extending from a closed bottom end 252 to an open top end 253. Thetop end 253 couples with a head member 255 having a pair of outwardlyextending opposed top flanges 254. The flanges 254 have through holes256 for receiving sutures to attach to the adapter ring 230, as will beexplained. The commissure constriction rod 226 is an assembly of the twocomponents—the tubular body 250 and the head member 255—so that it maybe held within the central aperture 242 of the valve holder 224. Thehead member 255 has downwardly-depending sidewalls 286 that surround thetop end 253 of the commissure constriction rod body 250 and split onboth sides in two projections 288 that fit within the similarly-sizedrecesses 290 on each side of the upper end of the rod body. To assemble,the bifurcated rod body 250 inserts up through the central aperture 242of the valve holder 224 on either side of a bridge 260 on the holder,after which the head member 255 adheres or otherwise fastens to the topend 253, as seen in FIGS. 19A and 19B.

The tubular body 250 of the rod 226 fits closely within the centralaperture 242 of the valve holder 224. The body 250 is bifurcated by apair of vertical slots 258 which permit passage around the bridge 260 onthe holder 224. The threaded nut 232 is centered on the bridge 260 andthus passes into the interior of the bifurcated rod 226.

As seen in FIGS. 18A, 19A, and 19B, the commissure constriction rod 226in an undeployed position fits within the central aperture 242 of thevalve holder 224 with the majority of its body 250 above the level ofthe holder. The worm screw 222 resides within the bifurcated body 250 ofthe rod 226, and is placed therein by flexing apart the two sides of thebody. The bottom end of the worm screw 222 engages the threaded nut 232on the holder 224, while the top-end includes an outward shelf 262 thatabuts the underside of an inwardly-jutting ridge 264 at the top of therod body 250. The combination of the outward shelf 262 and ridge 264retain the worm screw 222 in the interior of the bifurcated body 250.The worm screw 222 further includes a keyed head 266 on its proximal endwhich faces up through the open top end of the rod body 250.

The screw couple 228 comprises a relatively short tubular member havinga proximal end 270 with a central opening leading to a lumen, a smallcircular rib 272 in a midsection thereof, and outward flange 274 towardsa distal end, and an open distal end 276 that includes a key (not shown)designed to mate and rotate the keyed head 266 of the worm screw 222.Although a rectangular design of keyed head 266 is shown, other meshingarrangements are possible. As seen in FIG. 19B, the flange 274 of thescrew couple 228 fits closely within the upper flanges 254 and rests onthe inward ridge 264 of the bifurcated rod body 250. The distal end 276extends downward such that the key therein engages the keyed head 266 ofthe worm screw 222.

Still with reference to FIGS. 17 and 19A/19B, the adapter ring 230comprises a ring-shaped body 280 featuring a pair of opposed flanges 282having through holes 284. The ring 230 extends down over the screwcouple 228 such that the proximal end 270 of the screw couple projectsupward, as seen in the assembled views. The screw couple 228 rotatesfreely within the central aperture of the adapter ring 230. The flanges282 of the ring 230 align with and rest on the flanges 254 of thecommissure constriction rod 226. The alignment of the flanges 254 of therod 226 and the flanges 282 of the adapter ring 230 ensures alignment ofthe through holes 256 on the rod flanges 254 and the through holes 284on the ring flanges 282. The assembled views show these flanges alignedand secured together with attachment sutures 292.

As seen by the sectional assembly in FIG. 19B, rotation of the screwcouple 228 causes rotation of the worm screw 222. The screw couple 228may be rotated by threading the distal end of a conventional valvedelivery handle (e.g., handle 150 discussed above) into the opening atthe proximal end 270. Although not shown, the inner lumen of the screwcouple 228 may have internal threads that mate with threads on aconventional valve delivery handle. Because the worm screw 222 engagesthe threaded nut 232, clockwise rotation thereof translates the wormscrew downward. The bottom end of the worm screw 222 fits within a guidedepression 294 on the closed bottom end of the commissure constrictionrod 226. As the worm screw 222 moves downward, it pushes the commissureconstriction rod 226 relative to the surrounding valve holder 224.Ultimately, the worm screw 222 forces the rod 226 down into the positionshown in FIGS. 20A and 20B. Outwardly directed lockout pawls 296 on therod body 256 flex inward as they pass the inner circumference of thevalve holder 224, and then spring outward to prevent upward movement ofthe rod 226. Downward movement of the rod 226 eventually contacts thecrossed attachment sutures between the commissure post tips of theprosthetic heart valve 248, forcing them downward into tension whichpulls the commissure post tips inward. The valve delivery handle (notshown) may be left engaged with the screw couple 228 and used tomanipulate the heart valve into place at the target annulus.

Subsequently, the attachment sutures 292 between the adapter ring 230and the commissure constriction rod 226 are severed such that thecombination of the adapter sleeve and screw couple 228 may be removed,as indicated schematically in FIGS. 20A and 20B. The small circular rib272 (FIG. 20A) on the screw couple 228 retains the screw couple on theadapter ring 230 so that the two components may be removed together.This step opens up visibility of the valve holder 224 and attached heartvalve so that the surgeon can complete the implantation process.

FIG. 21 illustrates a prosthetic heart valve storage system 300 havingthe capacity to automatically constrict the heart valve commissures uponopening a storage jar. In particular, system includes structure withinthe storage jar that actuates a mechanism in a heart valve holder forpulling the valve commissure post tips inward upon detaching a jar lidfrom a bottom portion. The system 300 comprises a storage jar having abottom portion 302 and a lid 304 that screws thereon. A perforated,generally tubular packaging sleeve 306 fits closely within the jarbottom portion 302 and defines an inner space therein. A packaging clip308 removably attaches to the top of the sleeve 306 via a plurality ofupstanding fingers 310 on the sleeve that mate with openings 312 on theclip.

The packaging clip 308 is generally disc-shaped and has an enlargedrectangular slot 314 open to one side whose edges engage a pair ofopposed ears 320 on a prosthetic heart valve holder 322. The holder 322may be similarly configured to those shown above, with three outwardlyextending legs 324 which may be secured to an inflow sewing ring of aprosthetic heart valve (not shown). As before, the attachment suturesextend along the commissures posts and cross over the commissure posttips, much like the valve shown in FIG. 3.

The valve holder 322 includes a central aperture 326 that receives acommissure constriction rod 328 having an upper flange 330. As seen inthe views of FIGS. 21 and 24A/24B, the rod 326 includes an inneractuating screw 332 that is engaged by a worm screw 334 extendingdownward from a center of the jar lid 304. The rod 326 has a generallytubular body 336 with a vertical rib 338 extending outward therefrom. Apair of cantilevered fingers 340 formed by slits in the tubular body 336feature lockout pawls 342. The vertical rib 338 engages a verticalchannel on the inner lumen of the valve holder 322 to prevent relativerotation between.

FIG. 23 is a perspective view looking up into the jar lid 324 toillustrate the worm screw 334 integrated therein, while FIG. 21 showsthe jar closed with the worm screw 334 inserted all the way through thecommissure constriction rod 328 and an adapter 350. The adapter includesinner threads to which a delivery handle can be attached formanipulating the holder 322 and attached valve during an implantprocedure. As with the adapter 44 from FIG. 1, the adapter 350 caneasily be removed along with the delivery handle by severing sutures(not shown) connecting the adapter to the commissure constriction rod328.

To assemble the system 300, the prosthetic heart valve (not shown) andits holder 322 are snapped into place within the rectangular slot 314 onthe packaging clip 308. The packaging clip 308 is then snapped intoplace over the top of the packaging sleeve 306, as seen in FIG. 25. Itshould be noted that the packaging sleeve 306 includes a plurality ofoutward protrusions 352 that provide one-way anti-rotational engagementwith the sidewalls of the jar bottom portion 302. FIG. 22 illustratesvertical rails 354 on the inside wall of the jar bottom portion 302. Theoutward protrusions 352 on the sleeve 306 comprise outer ends ofcantilevered fingers 356 that flex inward upon relative rotation in aclockwise direction (CW, looking down) within the bottom portion 302,while preventing relative counterclockwise (CCW) rotation therein. Moredetail of the anti-rotation cooperation between the sleeve 306 and thejar is provided in co-pending U.S. Pat. No. 8,839,957, entitledPROSTHETIC HEART VALVE PACKAGING SYSTEM, filed Feb. 14, 2011, whosecontents are expressly incorporated by reference herein.

FIG. 26 shows the assembly of FIG. 25 inserted up into the jar lid 304,again without the prosthetic heart valve for clarity. To reach thisposition, the assembly of FIG. 25 is advanced up the worm screw 334 byrotation. Specifically, the inner actuating screw 332 (FIG. 24B)threadingly engages the worm screw 334. Subsequently, the jar lid 306can be screwed down over the jar bottom portion 302, which typicallycontains preservative fluid. (It should be noted here that some newtechniques enable dry heart valve storage, and thus a preservativesolution is not absolutely required.) Because of the one-wayanti-rotation cooperation between the sleeve 306 and the jar bottomportion 302, the bottom portion cams the cantilevered fingers 356 inwardduring this step. The final assembly of the storage system 300 is seenin FIG. 21, with the commissure constriction rod 328 and adapter 350 inan undeployed, raised position relative to the holder 322.

At the time of unpacking the heart valve for use, a technician unscrewsthe jar lid 304 from the jar bottom portion 302. The cantileveredfingers 356 and outward protrusions 352 on the packaging sleeve 306interfere with the vertical rails 354 on the inside wall of the jarbottom portion 302 when the jar lid 304 is unscrewed (rotated CCW),which thus prevents the sleeve 306 from concurrently rotating. As aresult, the worm screw 334 contacts and displaces the inner actuatingscrew 332 as a worm screw and follower. This engagement cams thecommissure constriction rod 328 and adapter 350 downward through thevalve holder 322, and ultimately constricts the valve commissuresinward. As mentioned, the lockout pawls 342 on the cantilevered fingers340 flex inward and then spring outward under the holder 322 to lock thecommissure constriction rod 328 in its deployed configuration. The lid304 may then be removed, exposing the valve packaged within the jar withthe valve commissures already constricted. This configuration ensuresthat the simple act of unscrewing the jar lid deploys the commissureconstriction mechanism, thus eliminating any technical instructions. Theheart valve is ready to deliver and implant as soon as the jar isopened.

It should be understood that the automated mechanism for constrictingthe commissures could be incorporated into any of the embodimentsdescribed above. For instance, the jar lid might act on a separateelement such as the worm screw 222 shown in the embodiment of FIGS.16-20. Also, components within the various systems described herein canbe interchanged, such as by incorporating an adapter such as shown at 44in FIG. 1 into the system of FIGS. 16-20. In short, unless mutuallyexclusive, elements of one system may be transferred to other systems.Furthermore, in each embodiment a threaded member is used to displacethe respective commissure constriction rod; e.g., the threaded deliveryhandle 150, the worm screw 222, and the worm screw 334. Each of theseand other like devices can be collectively referred to as “threadedmembers.”

FIG. 27 shows components of a further prosthetic heart valve storagesystem similar to that shown in FIGS. 21-22, but having an alternativeholder clip 360 attached to the top of a packaging sleeve 306. Likeparts will be given like part numbers. As before, the clip 360 retains avalve holder 322 suspended over the cavity within the sleeve 306.Specifically, the holder 322 includes a pair of opposed ears 320 thatare retained on a further central aperture edge 362 of the clip 360, asseen in FIG. 28.

As detailed in FIG. 28, the alternative holder clip 60 includes twohalves 364 a, 364 b that mesh together generally along a diametricmid-line and combine to form a circular disk. Each clip half 364 a, 364b includes a pair of tab extensions 370 and a pair of tab receptacles372, one of each on either side of the central aperture edge 362. Eachtab extension 370 fits closely into a tab receptacle 372 of the otherhalf—with the extensions above the receptacles. The combination is seenin FIG. 27.

FIG. 29 shows the prosthetic heart valve storage system components ofFIG. 27 assembled, with the valve holder 322 retained on the holder clip360. The holder clip 360 fastens to the top of the packaging sleeve 306such as via the upstanding fingers 310 on the sleeve within notches oropenings in the clip (not shown). The commissure constriction rod 328 isshown in the raised position which occurs by opening the jar lid asdescribed above. The sleeve 306 may be removed from the jar or left onplace prior to removal of the valve therefrom.

FIGS. 30A and 30B illustrate two steps in a process of removing aprosthetic heart valve 380 from within the packaging sleeve 306 bysimply pulling it up past the alternative holder clip 360. First, adelivery handle or rod 382 screws into the throughbore of the adapter350 coupled to the commissure constriction rod 328. While bracing thesleeve 306 and/or clip 360, the user pulls the rod 382 upward causingthe holder 322 and valve 380 to bend the inner edges of the clip halves364 a, 364 b upward, and eventually to pull free of the clip 360. Thematerial of the clip 360 is such that the tab extensions 370 are easilyflexed upward (unfold) to present minimal resistance to removal of thevalve 380. One possible material is a flexible nylon or polyethylene. Inthis way, the technician need not first remove the clip with the valvefrom the sleeve, and then pull the clip off of the valve holder—bothsteps are done at once.

Additionally, the design of the tab extensions 370 and tab receptacles372 is such that they provide some stiffness to downward pressure.Therefore, the delivery rod 382 can be pushed downward against areaction force while screwing it into the adapter 350. The clip 360 mayalso be retrofit to other valve packaging systems, and is not limited tothe environment shown.

While the foregoing is a complete description of the preferredembodiments of the invention, various alternatives, modifications, andequivalents may be used. Moreover, it will be obvious that certain othermodifications may be practiced within the scope of the appended claims.

What is claimed is:
 1. A method for preparing and deploying a prostheticmitral valve with reduced suture entanglement, the method comprising:opening a storage jar having a bottom portion and a jar lid attachedthereon by detaching the jar lid from the bottom portion, the bottomportion containing a prosthetic mitral valve having an inflow end, anoutflow end, and a flow axis therebetween, the valve further including aplurality of generally axially-extending flexible commissure posts thatend in tips circumferentially-spaced around the outflow end that supportoccluding flexible leaflets of the valve, wherein detaching the jar lidfrom the bottom portion automatically activates a commissureconstriction mechanism to flex the commissure post tips inward; removingthe valve from within the storage jar; threading an array ofimplantation sutures pre-installed at a mitral valve annulus through asewing ring of the valve; advancing the valve along the array ofimplantation sutures until the sewing ring contacts the mitral valveannulus, the valve being advanced with the commissure posts leading andthe commissure post tips flexed inward to reduce entanglement betweenthe implantation sutures and the commissure posts; tying down theimplantation sutures; and de-activating the commissure constrictionmechanism to permit the commissure posts to flex outward.
 2. The methodof claim 1, wherein a valve holder is attached to the inflow end of thevalve and the valve is stored in the storage jar with the inflow endoriented toward the jar lid, and wherein the step of removing the valvefrom within the storage jar comprises attaching a delivery handle to thevalve holder.
 3. The method of claim 2, wherein the commissureconstriction mechanism is connected to the valve holder, and wherein thevalve holder is attached to the sewing ring and detaching the valveholder from the sewing ring causes de-activation of the commissureconstriction mechanism.
 4. The method of claim 2, wherein the commissureconstriction mechanism comprises a commissure constriction rodconfigured to translate axially relative to the valve holder andpositioned with a distal end thereof adapted to hold a trefoilarrangement of attachment sutures spanning the commissure post tips in atented arrangement, thereby flexing the commissure posts radiallyinward, and wherein unscrewing the jar lid from the bottom portionadvances the commissure constriction rod axially from a proximalposition out of contact with the trefoil arrangement of attachmentsutures to a distal position in contact with the trefoil arrangement ofattachment sutures.
 5. The method of claim 4, wherein the commissureconstriction rod includes opposed lockout pawls on cantilevered fingersthat flex inward during passage through the valve holder and springoutward underneath the valve holder to maintain the commissureconstriction rod in the deployed position.
 6. The method of claim 2,further including a packaging sleeve that fits closely within thestorage jar bottom portion and a holder clip attached to the top ofpackaging sleeve, the holder clip having a central aperture that retainsthe valve holder suspended over a cavity within the packaging sleeve,the method including removing an assembly of the valve holder, valve,holder clip, and packaging sleeve from the storage jar, detaching thepackaging sleeve from the holder clip, and detaching the holder clipfrom the valve holder.
 7. The method of claim 2, further including apackaging sleeve that fits closely within the storage jar bottom portionand a holder clip attached to the top of packaging sleeve, the holderclip having a central aperture that retains the valve holder suspendedover a cavity within the packaging sleeve, wherein the holder clipcomprises two flexible halves that mesh together along a mid-line in amanner that resists downward movement of the valve holder but permitsthe valve holder and heart valve to be axially pulled upward free of theholder clip, the method including removing an assembly of the valveholder and valve from the storage jar by pulling it through the twoflexible halves of the holder clip.
 8. The method of claim 1, includingstructure attached to the jar lid that activates the commissureconstriction mechanism when detaching the jar lid from the bottomportion.
 9. The method of claim 6, wherein the structure attached to thejar lid includes a male threaded member projecting downward from the jarlid, and the commissure constriction mechanism includes a femalethreaded nut that the male threaded member engages, wherein detachingthe jar lid from the bottom portion comprises unscrewing the jar lidfrom the bottom portion.
 10. The method of claim 7, wherein a valveholder is attached to the inflow end of the valve and the valve isstored in the storage jar with the inflow end oriented toward the jarlid, and wherein the valve holder has a central aperture, and thecommissure constriction mechanism comprises a commissure constrictionrod configured to translate axially relative to the valve holder andpositioned with a distal end thereof adapted to hold a trefoilarrangement of attachment sutures spanning the commissure post tips in atented arrangement, thereby flexing the commissure posts radiallyinward, the commissure constriction rod having the female threaded nuttherein, wherein unscrewing the jar lid from the bottom portion rotatesthe male threaded member which in turn axially advances the femalethreaded nut and commissure constriction rod axially from a proximalposition out of contact with the trefoil arrangement of attachmentsutures to a distal position in contact with the trefoil arrangement ofattachment sutures
 11. A method for preparing and deploying a prostheticmitral valve with reduced suture entanglement, the method comprising:opening a storage jar having a bottom portion and a jar lid attachedthereon by detaching the jar lid from the bottom portion, the bottomportion containing a prosthetic mitral valve having an inflow end, anoutflow end, and a flow axis therebetween, the valve further including aplurality of generally axially-extending flexible commissure posts thatend in tips circumferentially-spaced around the outflow end that supportoccluding flexible leaflets of the valve, wherein a valve holder isattached to the inflow end of the valve and the valve is stored in thestorage jar with the inflow end oriented toward the jar lid, and whereina holder clip held within the jar retains the valve holder suspended inthe jar, activating a commissure constriction mechanism to flex thecommissure post tips inward, the commissure constriction mechanismcomprising a commissure constriction rod configured to translate axiallyrelative to the valve holder and positioned with a distal end thereofadapted to hold a trefoil arrangement of attachment sutures spanning thecommissure post tips in a tented arrangement, thereby flexing thecommissure posts radially inward, the commissure constriction mechanismactivated by rotating a first threaded member engaged with a secondthreaded member of the commissure constriction mechanism to cause one ofthe first or second threaded member to translate axially relative to thevalve holder and simultaneously causing the commissure post tips to flexinward; removing the valve holder and valve from the storage jar;threading an array of implantation sutures pre-installed at a mitralvalve annulus through a sewing ring of the valve; advancing the valvealong the array of implantation sutures until the sewing ring contactsthe mitral valve annulus, the valve being advanced with the commissureposts leading and the commissure post tips flexed inward to reduceentanglement between the implantation sutures and the commissure posts;tying down the implantation sutures; and de-activating the commissureconstriction mechanism to permit the commissure posts to flex outward.12. The method of claim 11, further including a packaging sleeve thatfits closely within the storage jar bottom portion to a top of which theholder clip attaches, the holder clip having a central aperture thatretains the valve holder suspended over a cavity within the packagingsleeve such that the prosthetic heart valve resides within the cavity ofthe packaging sleeve, and wherein the step of removing the valve holderand valve from the storage jar comprises attaching a delivery handle tothe valve holder and removing an assembly of the valve holder, valve,holder clip, and packaging sleeve from the storage jar, then detachingthe packaging sleeve from the holder clip, and detaching the holder clipfrom the valve holder.
 13. The method of claim 11, wherein the holderclip has a central aperture that retains the valve holder suspended overa cavity within the storage jar bottom portion, the holder clipcomprising two flexible halves that mesh together along a mid-line in amanner that resists downward movement of the valve holder but permitsthe valve holder and valve to be axially pulled upward free of theholder clip, and wherein the step of removing the valve holder and valvefrom the storage jar comprises removing an assembly of the valve holderand valve from the storage jar by pulling it through the two flexiblehalves of the holder clip.
 14. The method of claim 11, wherein the firstthreaded member is a male threaded member, and the second threadedmember is a female threaded portion that translates axially relative tothe valve holder and causes the commissure post tips to flex inward. 15.The method of claim 14, wherein the male threaded member is attached tothe jar lid and projects downward from the jar lid, wherein detachingthe jar lid from the bottom portion comprises unscrewing the jar lidfrom the bottom portion.
 16. The method of claim 11, wherein the firstthreaded member is a male threaded member on a distal end of a deliveryhandle, and the second threaded member is a female threaded nut on thevalve holder, wherein the male threaded member engages and advancesthrough the female threaded nut on the valve holder and causes thecommissure post tips to flex inward.
 17. The method of claim 11, whereinthe first threaded member is a male threaded worm screw positionedwithin the commissure constriction rod, and the second threaded memberis a female threaded nut on the valve holder, wherein the male threadedworm screw engages and advances through the female threaded nut on thevalve holder and causes the commissure post tips to flex inward.
 18. Themethod of claim 11, wherein the commissure constriction rod includesopposed lockout pawls on cantilevered fingers that flex inward duringpassage through the valve holder and spring outward underneath the valveholder to maintain the commissure constriction rod in the deployedposition.
 19. The method of claim 11, wherein the commissureconstriction mechanism is connected to the valve holder, and wherein thevalve holder is attached to the sewing ring and detaching the valveholder from the sewing ring causes de-activation of the commissureconstriction mechanism.
 20. The method of claim 11, wherein an assemblyof the valve holder and valve is removed from the storage jar prior tothe step of activating the commissure constriction mechanism.